NCT00564811

Brief Summary

The aim of the study was to verify the influence of Agaricus blazei (Murrill) ss. Heinemann (A. blazei) on the evolution of nutritional state and liver function in hepatitis C patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

First QC Date

November 27, 2007

Last Update Submit

May 27, 2015

Conditions

Hepatitis CNutritional StatusHepatitis, Viral, Human

Keywords

Agaricus blazei (Murrill) ss. Heinemann,Hepatitis CNutritional statusLiver Function TestsAntiviral Agents

Outcome Measures

Primary Outcomes (1)

  • Measure: influence of Agaricus blazei (Murrill) ss. Heinemann on the evolution of nutritional state and liver function in hepatitis C patients. Time Frame: six months

    Time Frame: six months

Study Arms (2)

G1

NO INTERVENTION

G2

EXPERIMENTAL
Dietary Supplement: Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)

Interventions

Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)DIETARY_SUPPLEMENT

Agaricus blazei powder, 10 grams/day, for 5 months

G2

Eligibility Criteria

Age24 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To have been informed and signed adequately the free and clarified assent
  • Initiating the anti-viral treatment (interferon or pegylated interferon associate the ribavirin)
  • Age: 24-70 years
  • Gender :both the gender
  • Race : all races
  • To present serology positive to the anti-VHC ELISA
  • To present genotype type 1,2,or 3
  • Body mass index- \>18,5 e \< 35kg /m2
  • Conditions full to the ORAL ingestion

You may not qualify if:

  • Don't agree to the project or don't have signed the term of clarified free assent
  • Restriction for oral ingestion
  • The existence of surface of antigen of the hepatitis B virus(Ag HBs)
  • The existence of antibody for the human immunodeficiency virus
  • To be enclosed in another project of research or form of treatment
  • Pregnant women
  • Suckles
  • Cirrhosis
  • Patients with hepatitis auto-imune.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal Medicine Department, Botucatu School of Medicine, São Paulo State University - UNESP

Botucatu, São Paulo, 18618-000, Brazil

Location

MeSH Terms

Conditions

Hepatitis CHepatitis, Viral, Human

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Caramori A Carlos, MD, PhD

    Botucatu Medicine School - Sao Paulo State University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 28, 2007

Study Start

March 1, 2003

Study Completion

September 1, 2004

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

BR(1)